EP3769781B1 - Stabile anti-ifnar1-formulierung - Google Patents
Stabile anti-ifnar1-formulierung Download PDFInfo
- Publication number
- EP3769781B1 EP3769781B1 EP20174805.0A EP20174805A EP3769781B1 EP 3769781 B1 EP3769781 B1 EP 3769781B1 EP 20174805 A EP20174805 A EP 20174805A EP 3769781 B1 EP3769781 B1 EP 3769781B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- antibody
- formulation
- lysine
- buffer
- histidine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Claims (12)
- Antikörperformulierung, die Folgendes umfasst:a. 100 bis 200 mg/ml Anifrolumab;b. 0,02 % bis 0,08 % eines Tensids, wobei das Tensid aus der aus Polysorbat 20, Polysorbat 80 und Poloxamer bestehenden Gruppe ausgewählt ist;c. 100 mM bis 150 mM eines ungeladenen Exzipienten, wobei der ungeladene Exzipient aus der aus Fructose, Glucose, Mannose, Sorbose, Xylose, Lactose, Maltose, Saccharose, Dextran, Pullulan, Dextrin, Cyclodextrinen, löslicher Stärke, Trehalose, Sorbit, Erythrit, Isomalt, Lactit, Maltit, Xylit, Glycerin, Lactit, Hydroxyethylstärke und wasserlöslichen Glucanen bestehenden Gruppe ausgewählt ist;d. einen Formulierungspuffer; unde. 25 bis 130 mM eines Lysinsalzes;wobei die Formulierung einen pH von 5,5 bis 6,5 aufweist
und wobei die Formulierung bei 25 °C eine Viskosität von gleich oder weniger als 20 mPas aufweist. - Antikörperformulierung nach Anspruch 1, wobei die Formulierung einen pH von 5,9 aufweist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei das Lysinsalz aus der aus Lysinacetat, Lysinmonochlorid, Lysindichlorid, Lysin-L-asparat, Lysin-L-glutamat und Lysin-HCl bestehenden Gruppe ausgewählt ist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei das Tensid Polysorbat 80 ist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei die Formulierung 0,05 % eines Tensids umfasst.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei der Formulierungspuffer ein Acetatpuffer, TRIS-Puffer, HEPES-Puffer, Hydrochloridpuffer, Argininpuffer, Glycinpuffer, Citratpuffer, Histidinpuffer oder TES-Puffer ist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei der Formulierungspuffer ein Histidinpuffer ist, wobei der Histidinpuffer gegebenenfalls Histidinhydrochlorid umfasst.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei der Formulierungspuffer Histidin/Histidinhydrochlorid ist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei der Formulierungspuffer 10 mM bis 40 mM Histidin/Histidinhydrochlorid umfasst, wobei der Puffer gegebenenfalls 25 mM Histidin/Histidinhydrochlorid umfasst.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei der ungeladene Exzipient aus der aus Glucose, Saccharose, Trehalose und Glycerin bestehenden Gruppe ausgewählt ist, wobei der ungeladene Exzipient gegebenenfalls Trehalose ist, wobei der ungeladene Exzipient gegebenenfalls Trehalosedihydrat ist.
- Antikörperformulierung nach einem der vorangegangenen Ansprüche, wobei die Formulierung zur intravenösen, subkutanen oder intramuskulären Verabreichung geeignet ist.
- Vorgefüllte Spritze, die eine Antikörperformulierung nach einem der Ansprüche 1 bis 11 enthält.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP23160045.3A EP4233892A3 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| HRP20230463TT HRP20230463T1 (hr) | 2015-08-19 | 2016-08-18 | Stabilna anti-ifnar1 formulacija |
| RS20230447A RS64263B1 (sr) | 2015-08-19 | 2016-08-18 | Stabilna anti-ifnar1 formulacija |
| SI201631699T SI3769781T1 (sl) | 2015-08-19 | 2016-08-18 | Stabilna formulacija proti-IFNAR1 |
| CY20231100289T CY1126062T1 (el) | 2015-08-19 | 2023-06-20 | Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562207164P | 2015-08-19 | 2015-08-19 | |
| EP16837818.0A EP3337502B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| PCT/US2016/047506 WO2017031288A1 (en) | 2015-08-19 | 2016-08-18 | Stable anti-ifnar1 formulation |
Related Parent Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP16837818.0A Division EP3337502B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| EP16837818.0A Division-Into EP3337502B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23160045.3A Division EP4233892A3 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| EP23160045.3A Division-Into EP4233892A3 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP3769781A1 EP3769781A1 (de) | 2021-01-27 |
| EP3769781B1 true EP3769781B1 (de) | 2023-04-19 |
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Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP16837818.0A Active EP3337502B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| EP23160045.3A Pending EP4233892A3 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| EP20174805.0A Active EP3769781B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP16837818.0A Active EP3337502B1 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
| EP23160045.3A Pending EP4233892A3 (de) | 2015-08-19 | 2016-08-18 | Stabile anti-ifnar1-formulierung |
Country Status (24)
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| EP (3) | EP3337502B1 (de) |
| JP (3) | JP6720293B2 (de) |
| KR (3) | KR20200119916A (de) |
| CN (1) | CN107921109A (de) |
| AU (3) | AU2016308262C1 (de) |
| BR (1) | BR112018002196A8 (de) |
| CA (1) | CA2995222C (de) |
| CY (2) | CY1123657T1 (de) |
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| RU (1) | RU2731737C2 (de) |
| SG (1) | SG10202106970XA (de) |
| SI (2) | SI3337502T1 (de) |
| WO (1) | WO2017031288A1 (de) |
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| ES2818229T3 (es) | 2015-08-19 | 2021-04-09 | Astrazeneca Ab | Formulación anti-IFNAR1 estable |
| GB201719447D0 (en) | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
| US20200061015A1 (en) * | 2018-08-23 | 2020-02-27 | Janssen Biotech, Inc. | Lipase Degradation Resistant Surfactants for Use in Large Molecule Therapeutic Formulations |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
| WO2021094378A1 (en) * | 2019-11-11 | 2021-05-20 | Astrazeneca Ab | Type i interferon inhibition in systemic lupus erythematosus |
| EP4157873A2 (de) | 2020-05-29 | 2023-04-05 | Astrazeneca AB | Behandlung von kardiometabolischen erkrankungen mit inhibitoren der typ i interferon signalübertragung |
| CN116547299A (zh) | 2020-06-25 | 2023-08-04 | 米迪缪尼有限公司 | 使用结合淀粉样蛋白β1-42肽的抗体来预防神经元轴突损伤 |
| TW202237647A (zh) | 2020-10-08 | 2022-10-01 | 瑞典商阿斯特捷利康公司 | 狼瘡發作之治療 |
| CA3216395A1 (en) | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Treatment of lupus nephritis with anti-type i inf receptor antibody anifrolumab |
| WO2022223770A1 (en) | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Treatment of cutaneous lupus erythematous |
| HRP20231255T1 (hr) | 2021-04-23 | 2024-02-02 | Astrazeneca Ab | Režim doziranja anti-ifnar1 za potkožnu injekciju |
| BR112023023391A2 (pt) | 2021-05-12 | 2024-01-23 | Astrazeneca Ab | Inibidor de diminuição de esteroide de receptor de interferon tipo 1 em pacientes com lúpus eritematoso sistêmico |
| CN113527490B (zh) * | 2021-07-13 | 2022-03-01 | 江苏荃信生物医药股份有限公司 | 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法 |
| CN113521276B (zh) * | 2021-07-13 | 2022-04-12 | 江苏荃信生物医药股份有限公司 | 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂 |
| WO2023284073A1 (zh) * | 2021-07-13 | 2023-01-19 | 江苏荃信生物医药股份有限公司 | 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂 |
| CA3226744A1 (en) | 2021-07-27 | 2023-02-02 | Astrazeneca Ab | Treatment of lupus |
| WO2023057369A2 (en) | 2021-10-04 | 2023-04-13 | Astrazeneca Ab | Treatment of lupus |
| WO2023073469A1 (en) * | 2021-10-29 | 2023-05-04 | Intas Pharmaceuticals Ltd. | STABLE LYOPHILIZED FORMULATION OF AN ANTI-α4ß7 ANTIBODY |
| TW202337497A (zh) * | 2022-02-18 | 2023-10-01 | 中國大陸商重慶明道浩悅生物科技有限公司 | 鼻內調配物及抗sars-cov-2棘蛋白抗體 |
| WO2024009205A1 (en) * | 2022-07-06 | 2024-01-11 | Intas Pharmaceuticals Ltd. | STABLE LIQUID FORMULATION OF AN ANTI-Α4ß7 ANTIBODY |
| WO2024079241A1 (en) | 2022-10-13 | 2024-04-18 | Astrazeneca Ab | Treatment of lupus |
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